11.080.30 消毒封装 标准查询与下载

AS EN 50103:2002 给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Provides guidance on concepts and objectives to be considered by a supplier of active medical devices when developing and maintaining a quality system.

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry.

NP EN 868-1-2000 已灭菌的医疗设备的包装材料和方法

1 Esta Norma Europeia especifica os requisitos e os métodos de ensaio para os materiais e sistemas de embalagem: - utilizados para embalar os dispositivos médicos que devem ser esterilizado; e - destinados a manter a esterilidade do dispositivo NOTA 1: Esta Norma foi elaborada como meio de estabelecer a conformidade com as respectivas Directivas Europeias. Se os estabelecimentos de saúde, por exemplo os hospitais, n?o colocam os dispositivos médicos no mercado, n?o est?o abrangidos por essas Directivas. Contudo, tais estabelecimentos de saúde devem respeitar os mesmos requisitos, tal como os fabricantes, mas podem utilizar meios alternativos para demonstrar a conformidade com esta Norma. NOTA 2: A conformidade com outras Partes da série da EN 868 pode ser utilizada para demonstrar a conformidade com um ou mais requisitos desta Norma. 2 Esta norma n?o se aplica aos materiais e sistemas de embalagem utilizados para embalar produtos fabricados asepticamente. 3 Esta Norma Europeia n?o descreve o sistema de garantia da qualidade para controlar todas as fases de fabrico. NOTA: Chama-se a aten??o para as normas relativas ao sistema da qualidade (ver e.g. EN ISO 9001, EN ISO 9002, EN 46001 ou EN 46002) que controlam todas as fases de fabrico incluindo o processo de esteriliza??o. N?o é requisito desta norma possuir um sistema da qualidade completo durante o fabrico, mas podem ser aplicados certos elementos de um tal sistema.

Packaging materials and systems for medical devices which are to be sterilized Part 1:General requirements and test methods

BS EN 868-9:2000 准备消毒的医疗装置用的包装材料和系统.用于生产热密封袋,卷轴和合盖的非包敷的非纺织聚烯烃材料.要求和试验方法

This part of EN 868 provides examples of particular requirements for uncoated nonwoven materials of polyolefines suitable for use as packaging of medical devices which are to be terminally sterilized. It introduces no additional requirements to the general requirements of part 1. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of part 1. The material specified in this part of the series EN 868 is intended for use in part or complete manufacture of heat sealable pouches, form and fill packs and lidding materials for packs.

Packaging materials and systems for medical devices which are to be sterilized - Uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods

BS EN 868-7:1999 准备消毒的医疗设备用的包装材料和系统.经环氧乙烷或辐射消毒的生产医用热密封包裹的粘性涂覆纸.要求和试验方法

This part of the series of EN 868 provides examples of particular requirements and test methods for heat sealable adhesive coated paper manufactured from paper complying with EN 868-6, for use as packaging of medical devices which are to be terminally sterilized with ethylene oxide or irradiation. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2 to 4.6 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1.

Packaging materials and systems for medical devices which are to be sterilized - Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods

BS EN 868-2:1999 准备消毒的医疗设备用的包装材料和系统.消毒包裹物.要求和试验方法

This part of the series of EN 868 provides examples of particular requirements and test methods for sterilization wrap suitable for use as packaging of medical devices which are to be terminally sterilized. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1. NOTE If the intended use as specified by the manufacturer includes the possibility of the material being used for other applications (e.g. sterile field, container filter or as an inner wrap for containers), then additional and/or other requirements can apply.

Packaging materials and systems for medical devices which are to be sterilized - Sterilization wrap - Requirements and test methods

BS EN 868-3:1999 准备消毒的医疗设备用的包装材料和系统.生产纸袋用的纸(EN 868-4中规定的)和生产盒和卷筒用的纸(EN 868-5中规定的).要求和试验方法

This part of the series of EN 868 provides examples of particular requirements and test methods for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5). It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1. Paper specified in this part is suitable for use as packaging of medical devices which are to be terminally sterilized.

Packaging materials and systems for medical devices which are to be sterilized - Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5): Requirements and test methods

BS EN 868-4:1999 准备消毒的医疗设备用的包装材料和系统.纸袋.要求和试验方法

This part of the series of EN 868 provides examples of particular requirements and test methods for paper bags manufactured from paper specified in Part 3 of this standard. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2 to 4.7 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1. Paper bags specified in this part are suitable for use as packaging of medical devices which are to be terminally sterilized.

Packaging materials and systems for medical devices which are to be sterilized - Paper bags - Requirements and test methods

BS EN 868-8:1999 准备消毒的医疗设备用的包装材料和系统.符合EN 285规定的蒸汽消毒器用的可重复使用的消毒容器.要求和试验方法

This part of the series of EN 868 provides examples of particular requirements and test methods for re-usable containers for steam sterilization. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2 to 4.7 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1. The containers specified in this part of the standard are intended to be used as a packaging system during the sterilization of medical devices in steam sterilizers conforming to EN 285 and the subsequent transportation and storage of those devices. NOTE 1 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e.g. operating temperature. NOTE 2 When goods are required to be multiple wrapped in order to fulfil the general requirements, they should first be packaged in a sterilization packaging material (e.g. a material as specified in other parts of this series of standards).

Packaging materials and systems for medical devices which are to be sterilized - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods

BS EN 868-5:1999 消毒的医疗设备用包装材料和系统.纸和塑料薄膜制的热和可自密封袋及卷绕材料.要求和试验方法

This part of the series of EN 868 provides examples of particular requirements and test methods for heat and self-sealable pouches and reels manufactured from paper complying with EN 868-3 and plastic film complying with clause 4 of this European Standard. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2, 4.3, 4.4, 4.5, 4.6 and 4.7 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1. Heat and self-sealable pouches and reels specified in this standard are suitable for use as packaging of medical devices which are to be terminally sterilized. The use of heat and self-sealable pouches and reels as primary packages enables ease of aseptic presentation where it is important for the user to be able to see the contents of the pack before it is opened.

Packaging materials and systems for medical devices which are to be sterilized - Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods

NF S98-051-2:1999 已消毒医疗设备用包装材料和系统.第2部分:消毒包.要求和试验方法

Packaging materials and systems for medical devices which are to be sterilized. Part 2 : sterilization wrap. Requirements and test methods.

ISO 14160:1998 使用液体化学灭菌剂对包括动物源材料在内的一次性使用医疗器具进行灭菌的确认和常规控制

This International Standard specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, of single-use medical devices comprising, in whole or in part, materials of animal origin. This International Standard does not apply to material of human origin. This International Standard does not describe a quality assurance system for the control of all stages of manufacture. NOTE 1 Attention is drawn to the standards for quality systems (see ISO 9001 and ISO 13485 or ISO 9002 and ISO 13488) which can be used in the control of all stages of manufacture including the sterilization process. This International Standard does not describe tests to establish the effects of any chosen sterilization method upon the fitness for use of the medical device. NOTE 2 Such testing is a crucial part of the design and development of a medical device. This International Standard does not describe methods for the validation of the inactivation of viruses. NOTE 3 In developing a method for processing medical devices containing materials of animal origin, consideration of the effects of liquid chemical sterilization on potential viral contaminants will also be necessary because of the source of materials used in the manufacture of these particular medical devices. The importance of validation of viral inactivation for processes within the scope of this International Standard is recognized. This aspect is excluded from this International Standard; a separate European Standard is in preparation (EN 12442-3). NOTE 4 Liquid chemical sterilants traditionally employed to sterilize animal tissues in medical devices may not be effective in inactivating the causative agents of transmissable spongiform encephalopathies such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this International Standard should not be assumed to demonstrate inactivation of infective agents of this type. This International Standard does not cover the level of residual sterilant within medical devices. NOTE 5 ISO 14538 is concerned with this issue.

Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid sterilants

BS EN 868-1:1997 准备进行消毒的医疗装置用的包装材料和系统.一般要求和试验方法

1 This European Standard specifies the requirements and test methods for packaging materials and systems: - which are used for packaging of medical devices which are to be terminally sterilized; and - which are intended to maintain sterility of the device. NOTE 1. This standard has been developed as a means to show compliance with relevant European Directives. If health care facilities e.g. hospitals do not place medical devices on the market, they are not covered by these Directives. Nevertheless, such health care facilities can fulfil the same requirements as manufacturers but can use alternative means to demonstrate conformity to this standard. NOTE 2. Compliance with other Parts of prEN 868 series can be used to demonstrate compliance with one or more of the requirements of this standard. 2 This standard does not apply to packaging materials and systems used for packaging aseptically manufactured products. 3 This European Standard does not describe a quality assurance system for control of all stages of manufacture. NOTE. Attention is drawn to the standards for quality systems (see e.g. EN ISO 9001, EN ISO 9002, EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system can be applied.

Packaging materials and systems for medical devices which are to be sterilized - General requirements and test methods

NF S98-051:1997 要消毒的医疗器材用包装材料和系统.第1部分:一般要求和试验方法

Packaging materials and systems for medical devices which are to be sterilized. Part 1 : general requirements and test methods.

ISO 11607:1997 终端无菌医学设备的包装

Packaging for terminally sterilized medical devices

AS 1079.3:1994 病人护理用物品（消毒）包装．纸袋．医疗保健设施一次性使用

Specifies requirements for single-use paper bags for packaging items to be sterilized by saturated steam and intended for use in health care facilities.

Packaging of items (sterile) for patient care - Paper bags - For single use in health care facilities

AS 1079.2:1994 病人护理用物品（消毒）包装．一次性纸张．医疗保健设施包裹消毒物品用

Specifies requirements for plain unimpregnated, impregnated and crepe paper intended for the wrapping of materials and equipment for sterilization in health care facilities by steam under pressure or by ethylene oxide.

Packaging of items (sterile) for patient care - Non-reusable papers - For the wrapping of goods undergoing sterilization in health care facilities

AS 1079.1:1993 病人护理用物品（消毒）包装．消毒处理物品包装材料的选择

Specifies sterilization-related performance requirements to be considered in the selection of packaging materials and packages intended for sterilization.

Packaging of items (sterile) for patient care - Selection of packaging materials for goods undergoing sterilization

DIN 58953-6:1987 消毒.消毒材料供应.制袋和软管包装用消毒纸.检验

This standard is valid for testing sterilization paper. In addition to physical test methods, the standard contains also requirements on germ density with microorganism.#,,#

Sterilization; sterile supply; sterilization paper for bags and tube packings; test

NF S90-321:1986 外科医疗器械.蒸气消毒用包、套、软片和卷筒尺寸

MEDICO-SURGICAL EQUIPMENT. BAGS,TUBE PACKINGS,SHEETS AND TOILS FOR STEAM-STERILIZATION. DIMENSIONS.

DIN 58952-2:1977 消毒.第2部分:消毒物品、金属制筐用包装材料

Sterilization; packing materials for sterilizing goods, sterilizing baskets made od metal

Sterilization; packing materials for sterilizing goods, sterilizing baskets made of metal